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Subject:
Shelf life of drug eluting stents
Category: Health > Conditions and Diseases Asked by: crystal4290-ga List Price: $20.00 |
Posted:
17 Apr 2005 17:55 PDT
Expires: 17 May 2005 17:55 PDT Question ID: 510603 |
What is the average shelf life for drug eluting stents for human use? I heard that they had very short shelf lives. | |
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Subject:
Re: Shelf life of drug eluting stents
Answered By: bobbie7-ga on 18 Apr 2005 14:43 PDT Rated: |
Dear Crystal4290, I'm delighted that my findings are helpful! I will repost them below for your convenience. Best wishes, Bobbie7 ----------------------------------------- It appears that the average shelf life of drug-eluting stents is six months. If this information serves your purpose, please let me know and I will post my findings as your official answer. Thanks, Bobbie7 Excerpts: FDA Approves Extension of Expiration Date for TAXUS? Express2? Paclitaxel-Eluting Stent System to Nine Months Decision adds three months to current U.S. shelf life of product ? Boston Scientific Corporation (NYSE: BSX - News) today announced that the U.S. Food and Drug Administration (FDA) has approved extending the shelf life of its TAXUS Express2 paclitaxel-eluting coronary stent system in the United States to nine months from the current shelf life of six months. The decision was based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the TAXUS system -- in particular the drug content, drug degradation profile, and drug-release mechanism -- was maintained within FDA- approved specifications at nine months. The extended expiration date applies to all sizes of the TAXUS system for sale in the United States. The Company said it would immediately begin updating labels to reflect the nine-month expiration date. The shelf life for the TAXUS system outside the United States remains unchanged at 18 months. August 2004 http://www.ptca.org/press_rel/20040819pr_boston.html Drug-eluting Stent news http://www.ptca.org/news_des.html Six months ?Cordis spokesperson Terri Mueller told HPN insisted that the company is "on target with its rollout plan in the U.S." But others say two factors have contributed to issues with availability. The first blip entails the product's relatively short shelf life (six months) because of its piggybacked pharmaceutical.? http://www.findarticles.com/p/articles/mi_m0BPC/is_8_27/ai_107199462 |
crystal4290-ga
rated this answer:
and gave an additional tip of:
$5.00
This is exactly what I wanted to know - and I even got the answer rapidly! Perfect! |
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Subject:
Re: Shelf life of drug eluting stents
From: bobbie7-ga on 18 Apr 2005 13:52 PDT |
Hello again Crystal4290, It appears that the average shelf life of drug-eluting stents is six months. If this information serves your purpose, please let me know and I will post my findings as your official answer. Thanks, Bobbie7 Excerpts: FDA Approves Extension of Expiration Date for TAXUS? Express2? Paclitaxel-Eluting Stent System to Nine Months Decision adds three months to current U.S. shelf life of product ? Boston Scientific Corporation (NYSE: BSX - News) today announced that the U.S. Food and Drug Administration (FDA) has approved extending the shelf life of its TAXUS Express2 paclitaxel-eluting coronary stent system in the United States to nine months from the current shelf life of six months. The decision was based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the TAXUS system -- in particular the drug content, drug degradation profile, and drug-release mechanism -- was maintained within FDA- approved specifications at nine months. The extended expiration date applies to all sizes of the TAXUS system for sale in the United States. The Company said it would immediately begin updating labels to reflect the nine-month expiration date. The shelf life for the TAXUS system outside the United States remains unchanged at 18 months. August 2004 http://www.ptca.org/press_rel/20040819pr_boston.html Drug-eluting Stent news http://www.ptca.org/news_des.html Six months ?Cordis spokesperson Terri Mueller told HPN insisted that the company is "on target with its rollout plan in the U.S." But others say two factors have contributed to issues with availability. The first blip entails the product's relatively short shelf life (six months) because of its piggybacked pharmaceutical.? http://www.findarticles.com/p/articles/mi_m0BPC/is_8_27/ai_107199462 |
Subject:
Re: Shelf life of drug eluting stents
From: bobbie7-ga on 18 Apr 2005 16:33 PDT |
Thank you very much for the five stars, kind words and nice tip! --Bobbie7 |
Subject:
Re: Shelf life of drug eluting stents
From: angiodude-ga on 26 May 2005 21:40 PDT |
The latest info (which has changed recently) is that the Taxus stent now has an approved shelf life of 12 months in the U.S. and 18 months outside. The Cypher stent has a 3 month shelf life approved for the U.S. and 5 months outside. News about this can be found at http://www.ptca.org/news_des.html#TAXUS_SHELF |
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